Late In-the-bag intraOcular Lens dislocatioN Surgery (LION)

Late In-the-bag intraOcular Lens dislocatioN Surgery: A Randomized Clinical Trial (LION Trial)

Overall aim of the study is to compare the safety and efficacy of two different surgical methods to treat Late In-the-bag intraocular lens dislocation.

Study Overview

• Status: Unknown
• Conditions: Intraocular Lens Dislocation
• Intervention / Treatment: Procedure: IOL repositioning; Procedure: IOL exchange

Detailed Description

Cataract is a condition of unclear lens that cause poor vision. The only treatment is surgery where the blurred biological lens is replaced with an artificial clear lens (IOL). Most people who operate achieve full vision. Nevertheless, serious complications may occasionally occur, and one of these is dislocation of the entire complex with IOL and lens capsule. This requires surgical treatment.

In this study the investigators want to compare two different surgical methods used in late dislocation of IOL inside the capsule after cataract surgery. Patients will be randomly affiliated to either the suturing of existing IOL / capsule complex, or lens exchange to an IOL fixed to the iris.

The focus of the trial will be especially on complications and other eye changes in the early stages of surgery. Today, little data is available on these topics, and the investigators believe that new knowledge can bring us closer to a response to preferred operating techniques and an optimal drug drop regime for the patient group.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marius Dalby, M.D. PhD Cand.; Phone Number: +47 92408957; Email: marius.dalby@gmail.com

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital
    • Contact: Olav Kristianslund, M.D. M.Phil. PhD cand.; Phone Number: +47 41625514; Email: olav.kristianslund@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• IOL inside the capsule ("in-the-bag")
• Late dislocation (more than 6 months after cataract surgery)
• IOL visible in the pupillary area in the supine position and hence possible to perform surgery with an anterior approach
• Eligibility for both operation methods
• Ability to cooperate fairly well during the examinations
• Willing to participate in the study, e.g. willingness to participate at all control visits

Exclusion Criteria:

• IOL designs that cannot be repositioned with a suture loop, such as plate-haptic IOLs without holes in the peripheral part
• Eyes with especially thin sclera
• Active uveitis or pronounced iris pathology
• Eyes with previously performed Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
• Totally dislocated IOL into the posterior segment of the eye requiring pars plana vitrectomy
• Eyes that prior to cataract extraction had a subluxated lens in need of surgery with a Cionni capsular tension ring (e.g. patients with Marfan syndrome and ectopia lentis)
• Cases requiring a change in refraction. Risk of severe anisometropia
• Patients unable to lie in supine position for surgery in local anesthesia, e.g. severe chronic obstructive pulmonary disease and severe heart failure
• Patients using anticoagulants that cannot be discontinued

For patients with dislocated IOLs in both eyes during the study period, only the first operated eye will be included. Patients without prospects of improvement in vision will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IOL repositioning group	Procedure: IOL repositioning; Intraocular lens repositioning by scleral suturing
Active Comparator: IOL exchange group	Procedure: IOL exchange; Intraocular lens exchange with retropupillary iris-claw lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation in the anterior chamber after surgery	Measured with a Laser Flare Meter	The first weeks after surgery
Changes in macular thickness and occurrence of Cystoid macular edema	Evaluated with Optical Coherence Tomography	The first months after surgery, and long term changes months up to two years after surgery
Intraocular pressure changes	Measured with Goldmann Applanation Tonometry and iCare, both measured in mmhg	Early changes in the first weeks after surgery, and long term changes months up to two years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Visual acuity (BCVA)	Measured in LogMar	Short term (the first weeks and up to 6 months) and long term (up to two years)
Best Corrected Visual acuity (BCVA)	Measured in Snellen	Short term (the first weeks and up to 6 months) and long term (up to two years)
Glare	Measured by straylight meter	Medium term (6 months)
Glare	Measured by subjective presence of glare	Medium term (6 months)
Endothelial cells	Measured by Non-contact corneal confocal microscopy	Short term (2 weeks) and long term (6months and 2 years)
Intra- and postoperative complications	All relevant complications	Short term and long term (first post operative day, the first weeks and months, and up to two years)
IOL tilt	Measured with anterior segment Ultra Sound	6 months and 2 years
IOL tilt	Measured with Anterior segment optical coherence tomography	6 months and 2 years
Refractive outcomes - subjective refraction measured with a phoropter	To compare the refractive outcomes (short and long-term)	Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Refractive outcomes - subjective refraction measured with a phoropter	To determine whether suture placement for IOL repositioning affects the refractive outcome	Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Astigmatism	To compare astigmatism measured by keratometry	Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Astigmatism	To compare astigmatism measured by subjective refraction measured with phoropter	Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: South-Eastern Norway Regional Health Authority
• Investigators: Study Chair: Liv Drolsum, Prof. M.D. PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2017
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Cataract surgery; Cataract; IOL dislocation; Scleral suturing; Verisyse; Iris-claw; Late in-the-bag IOL dislocation
• Additional Relevant MeSH Terms: Eye Diseases; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Lens Diseases; Joint Dislocations; Lens Subluxation
• Other Study ID Numbers: 2017/5506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No